Forehead supports for facial masks

ABSTRACT

A forehead support for a mask assembly includes a frame connector provided to a mask frame, a forehead cushion support movably mounted to the frame connector for generally linear movement between retracted and extended positions with respect to the frame connector, and an adjustment knob movably mounted to the frame connector and threadably engaged with the forehead cushion support such that turning movement of the adjustment knob causes the forehead cushion support to be moved between the retracted and extended positions. The adjustment knob includes a resilient prong having a ratchet bump. The ratchet bump is adapted to selectively engage a series of ridges provided to the frame connector to provide indexed incremental adjustment.

CROSS-REFERENCE TO APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/350,475, filed Jan. 13, 2012, which is a continuation of U.S.application Ser. No. 12/308,462, filed Dec. 16, 2008, now U.S. Pat. No.8,327,850, which is the U.S. national phase of International ApplicationSerial No. PCT/AU2007/000837, filed Jun. 15, 2007, which designated theU.S. and claims the benefit of U.S. Provisional Patent Application Ser.Nos. 60/814,056, filed Jun. 16, 2006, 60/836,604, filed Aug. 10, 2006,and 60/858,694, filed Nov. 14, 2006, each of which is incorporatedherein by reference in its entirety.

Also, PCT Application No. PCT/AU2006/000037, filed Jan. 12, 2006, isincorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates generally to the field of foreheadsupports for facial masks used to supply breathable gas to a wearer'sairways.

BACKGROUND OF THE INVENTION

Facial masks are well known for use in continuous positive airwaypressure (CPAP) treatment of various respiratory ailments and sleepdisordered breathing (SDB), such as, for example, obstructive sleepapnea (OSA) and/or other ventilatory assistance treatments such asnoninvasive positive pressure ventilation (NPPV). See, for example, U.S.Pat. No. 4,944,210, the entire content of which is expresslyincorporated hereinto by reference.

Apparatus for the treatment of SDB generally involves a blower whichdelivers a supply of air at positive pressure to a patient interface viaa conduit. The patient interface may take several forms, such as a nasalmask assembly and a nasal and mouth mask assembly (i.e., a full facemask). Patients typically wear a mask assembly while sleeping to receivethe NPPV therapy.

Mask assemblies typically include a rigid shell or frame and a softface-contacting cushion. The cushion cushions the rigid frame from thepatient's face, and provides a seal with the patient's face. The frameand cushion define a cavity which receives the nose or nose and mouth.The frame and cushion are held in position on the patient's face by aheadgear assembly. The headgear assembly typically comprises anarrangement of straps which pass along both sides of the patient's faceto the back or crown of the patient's head.

One problem that arises with existing masks used for CPAP treatments isthat tightening of the mask straps results in compression of the maskagainst the wearer's face which may therefore apply undue force againstcertain of the wearer's facial features, such as the wearer's nose. Apoorly fitting mask can leak when pressurized which encourages a patientto tighten the headgear straps excessively which, in turn leads todiscomfort, marks on the face and in some cases facial sores.

Thus, conventional masks have been provided with a forehead support,which provides a support and stability mechanism between the mask andthe forehead. The forehead support prevents both the mask from pushingtoo strongly against the wearer's facial region as well as minimizingmovement of the mask with the addition of a contact point between themask and the wearer's head thereby reducing uncomfortable pressurepoints. Furthermore, in facial masks having a gusseted facial cushionsuch as described in co-pending U.S. Provisional Patent Application Ser.No. 60/643,113, filed Jan. 12, 2005, the entire content of which isexpressly incorporated hereinto by reference, a forehead support may beemployed to control the amount of gusset opening and/or closing therebyassisting in the applied force to the wearer's face, for example, thepatient's nasal region.

Typically, a mask forehead support is adjustable so that a standard maskmay be capable of adjustment suitable for a number of patients withdifferent anthropometric features. Conventional masks having adjustableforehead supports are evidenced by U.S. Pat. Nos. 6,119,693; 6,463,931;6,557,556; and 6,691,708, the entire content of each such prior-issuedpatent being incorporated expressly hereinto by reference. To facilitateadjustability, conventional forehead supports may also be capable ofdisplacement relative to the mask as shown, for example, in U.S. Pat.No. 6,532,961 (the entire content of which is expressly incorporatedhereinto by reference), so as to provide a means by which the relativeangle between the mask and the forehead support can be varied toaccommodate the facial features of a particular wearer.

A problem with conventional forehead supports for masks, however, isthat the range of adjustment is relatively limited which therefore doesnot in fact provide a universal fit for a relatively large number ofwearers. That is, due to the anthropometric features of a particularuser's head, the adjustability of conventional forehead supports may notbe sufficient to allow for a comfortable fit. Thus, while the foreheadsupports described above perform in a satisfactory manner, improvementsto forehead supports for masks are needed.

SUMMARY OF THE INVENTION

In one embodiment, a mask forehead support provides for greateruniversality of fit as compared to conventional forehead supportstructures. More specifically, according to embodiments of the presentinvention, forehead supports are provided which are capable of a moreuseful and beneficial range of adjustment as compared to conventionalforehead support structures thereby allowing the forehead supports ofthe present invention to more universally fit a much larger number ofpatients.

One aspect of the present invention relates to a forehead support for amask assembly including a frame connector provided to a mask frame, aforehead cushion support movably mounted to the frame connector forgenerally linear movement between retracted and extended positions withrespect to the frame connector, and an adjustment knob movably mountedto the frame connector and threadably engaged with the forehead cushionsupport such that turning movement of the adjustment knob causes theforehead cushion support to be moved between the retracted and extendedpositions. The adjustment knob includes a resilient prong having aratchet bump. The ratchet bump is adapted to selectively engage a seriesof ridges provided to the frame connector to provide indexed incrementaladjustment.

Another aspect of the present invention relates to a forehead supportfor a mask assembly including a frame connector provided to a maskframe, a forehead cushion support movably mounted to the frame connectorfor generally linear movement between retracted and extended positionswith respect to the frame connector, and an adjustment knob movablymounted to the frame connector. The knob includes a threaded shaft thatis threadably engaged with an internally threaded tube provided to theforehead cushion support such that turning movement of the adjustmentknob causes the forehead cushion support to be moved between theretracted and extended positions. The frame connector has a cut-out thatallows an upper portion of the tube to be visible.

Another aspect of the present invention relates to a forehead supportfor a mask assembly. The forehead support includes a frame connectorprovided to a mask frame, a forehead cushion support movably mounted tothe frame connector for generally linear movement between retracted andextended positions with respect to the frame connector, and anadjustment knob movably mounted to the frame connector. The knobincludes a threaded shaft that is threadably engaged with an internallythreaded tube provided to the forehead cushion support such that turningmovement of the adjustment knob causes the forehead cushion support tobe moved between the retracted and extended positions. Position markingsare provided to the frame connector and/or the adjustment knob toindicate a position of the forehead cushion support.

It will of course be understood that, while the present invention willbe described in connection with a full facial mask, those in this artwill recognize that such a description represents one preferredembodiment and is thus non-limiting. Thus, the structural and/orfunctional features of the present invention may, for example, also beusefully employed in nasal masks or nasal prongs, nozzles, nare seals,and/or cannulae.

Other aspects, features, and advantages of this invention will becomeapparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of thisinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousembodiments of this invention. In such drawings:

FIGS. 1-1 to 1-10 show various views of a full facial mask assemblyincluding a forehead support according to an embodiment of the presentinvention;

FIGS. 2-1 to 2-7 show various views of a frame of the mask assemblyshown in FIGS. 1-1 to 1-10;

FIGS. 3-1 to 3-6 show various views of a frame connector of the foreheadsupport shown in FIGS. 1-1 to 1-10;

FIGS. 4-1 to 4-7 show various views of an adjustment knob of theforehead support shown in FIGS. 1-1 to 1-10;

FIGS. 5-1 to 5-7 show various views of a forehead cushion support of theforehead support shown in FIGS. 1-1 to 1-10;

FIGS. 6-1 to 6-7 show various views of a frame connector according toanother embodiment of the present invention;

FIGS. 7-1 to 7-8 show various views of an adjustment knob according toanother embodiment of the present invention;

FIGS. 8-1 to 8-7 show various views of a forehead cushion supportaccording to another embodiment of the present invention;

FIGS. 9-1 to 9-8 show various assembly views of the frame connector,adjustment knob, and forehead cushion support shown in FIGS. 6-1 to 6-7,7-1 to 7-8, and 8-1 to 8-7;

FIGS. 10-1 to 10-5 show position markings on a forehead cushion supportaccording to embodiments of the present invention;

FIGS. 11-1 to 11-15 show position markings provided to the frameconnector and/or the adjustment knob according to embodiments of thepresent invention;

FIGS. 12-1 to 12-8 show various views of an adjustment knob according toanother embodiment of the present invention;

FIG. 13 is a schematic view of a resilient prong for an adjustment knobaccording to another embodiment of the present invention;

FIGS. 14-1 to 14-8 show various views of an adjustment knob according toanother embodiment of the present invention;

FIGS. 15-1 to 15-4 show various views of a frame according to anotherembodiment of the present invention;

FIGS. 16-1 to 16-7 show various views of a forehead cushion supportaccording to another embodiment of the present invention;

FIGS. 17-1 to 17-7 show various views of a forehead cushion supportaccording to another embodiment of the present invention;

FIGS. 18-1 to 18-7 show various views of a forehead cushion supportaccording to another embodiment of the present invention; and

FIGS. 19-1 to 19-7 show various views of a forehead cushion supportaccording to another embodiment of the present invention.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS

The following includes descriptions of several illustrated embodimentsof the present invention, which may share common characteristics andfeatures. It is to be understood that one or more features of any oneembodiment may be combinable with one or more features of the otherembodiments. In addition, each single feature or combination of featuresin any of the embodiments may constitute an additional embodiment.

Each illustrated embodiment includes features that may be used with theembodiments and/or components described in PCT Application No.PCT/AU2006/000037, as would be apparent to those of ordinary skill inthe art. PCT/AU2006/000037 is incorporated herein by reference in itsentirety.

1. First Illustrated Embodiment of Forehead Support

FIGS. 1-1 to 1-10 illustrate a full facial mask assembly (“FMA”) 10including a forehead support 12 according to an embodiment of thepresent invention. As illustrated, the mask assembly 10 includes a frame14 (see FIGS. 2-1 to 2-7), a cushion 16 provided to the frame 14 andadapted to form a seal with the patient's face, an elbow assembly 18provided to the frame 14 and adapted to be connected to an air deliverytube that delivers breathable gas to the patient, and a forehead support12 (see FIGS. 2-1 to 5-7) to provide a support and stability mechanismbetween the mask assembly 10 and the patient's forehead. A headgearassembly (not shown) may be removably attached to the frame 14 and theforehead support 12 to maintain the mask assembly 10 in a desiredadjusted position on the patient's face.

Further details and embodiments of mask assemblies and forehead supportsare disclosed in PCT Application No. PCT/AU2006/000037, the entiretyincorporated herein by reference. While the forehead support 12 isdescribed as being implemented into a mask assembly of the typedescribed above, it may be implemented into other mask systems, e.g.,full-face mask, mouth mask, or a nasal mask.

In this embodiment, the forehead support 12 uses a screw-type actuatorto move the forehead support 12 along a generally linear path. The maincomponents of the forehead support 12 are a frame connector 20 (alsoreferred to as a support or a receiver) provided to the mask frame 14(see FIGS. 2-1 to 3-6), an adjustment knob 40 (also referred to as adial) including a threaded shaft 42 (see FIGS. 4-1 to 4-7), and aforehead cushion support 60 (also referred to as a t-bar) including aninternally threaded tube 62 (see FIGS. 5-1 to 5-7). The forehead cushionsupport 60 carries forehead cushions 90 that are adapted to engage thepatient's forehead in use (see FIGS. 1-1 to 1-10). Further details andembodiments of forehead cushions are disclosed in PCT Application No.PCT/AU2006/000037, the entirety incorporated herein by reference.

In an embodiment, the components may be assembled by first inserting theinternally threaded tube 62 of the forehead cushion support 60 into theframe connector 20, and then assembling the adjustment knob 40 to theframe connector 20 and the forehead cushion support 60. However, otherassembly sequences are possible, e.g., knob first and then foreheadcushion support such as the arrangements shown in FIGS. 16-1 to 19-7 forexample. Further details of assembly are described below.

When the adjustment knob 40 is rotated, the internally threaded tube 62of the forehead cushion support 60 extends or retracts from the threadedshaft 42 of the adjustment knob 40, which causes adjustable movement ofthe forehead cushions 90.

In an embodiment, the components may be disassembled by rotating theadjustment knob 40 until it releases from the internally threaded tube62 of the forehead cushion support 60, and then pulling off, e.g.,snapping off, the adjustment knob 40 from the frame connector 20. Thatis, the knob 40 is over-rotated or over-torqued at the end of travelalong the tube 62 to release the knob 40 from the tube 62 and the frameconnector 20. Next, the forehead cushion support 60 may be pulled out ofthe frame connector 20.

1.1 Forehead Cushion Support

As shown in FIGS. 5-1 to 5-7, the forehead cushion support 60 includesan internally threaded tube 62 joined to forehead cushion support plates64 that carry forehead cushions 90. As shown in best shown in FIGS. 5-2and 5-7, the support plates 64 include vertical reinforcing ribs 66 toprovide better flexing strength. Also, as best shown in FIG. 5-6, thesupport plates 64 are angled with respect to the tube 62, e.g., about15-25°, preferably 21°, from vertical.

The tube 62 includes two splits 68 that divide the tube 62 into tworesilient arms 70 which can deflect to allow insertion of the tube 62into the frame connector 20. In the illustrated embodiment, the splits68 extend to the cushion support plates 64. However, in an alternativeembodiment, the splits 68 may stop at any point along the tube 62 suchthat they allow sufficient deflection of the tube 62 into the frameconnector 20.

The internally threaded tube 62 includes key ways or elongated slots 72(e.g., three keyways) that receive respective protrusions 22 (e.g.,three protrusions) provided on the frame connector 20 (see FIGS. 3-2,3-3, and 3-5). This arrangement prevents the tube 62, and hence theforehead cushion support 60, from twisting or rotating relative to theframe connector 20. The use of an odd number of key ways 72 alsoprevents incorrect assembly of the forehead cushion support 60 to theframe connector 20.

As illustrated, a ridge or retention bump 74 is provided at the end ofeach key way 72. The ridges 74 force the arms 70 to deflect on assemblyto the frame connector 20 and prevent inadvertent disassembly of theforehead cushion support 60 from the frame connector 20. In theillustrated embodiment, a lead-in 75 is provided before each ridge 74(e.g., ridge 74 is spaced inwardly from the end of the tube 62, e.g., by5 mm) to aid alignment in assembly.

In the illustrated embodiment, the forehead cushion support plates 64include slots 76 for attaching headgear straps. The headgear straps mayinclude Velcro for length adjustment. A gap 78 is provided in eachsupport plate 64 to allow the headgear strap to be fitted withoutundoing the Velcro and losing the correct headgear length. Thisarrangement facilitates assembly and disassembly of the headgear strapsfrom the forehead cushion support plates 64.

In an embodiment, the width of the slots 76 for the headgear straps ispreferably 6 mm, and not more than 8 mm. This width constrains theheadgear straps to prevent excessive movement of the straps relative tothe slots 76.

It is noted that the forehead cushion support plates 64 may includeother suitable structures for engaging headgear straps, e.g., clipreceiving structures for engaging headgear clips.

The forehead cushion support 60 may be relatively thick and wide in someregions, e.g., wider upper wall 80 as shown in FIG. 5-3, to provide morestrength in bending and twisting of the forehead cushion support plates64.

1.2 Adjustment Knob

As shown in FIGS. 4-1 to 4-7, the adjustment knob 40 includes a threadedshaft 42. In the illustrated embodiment, the threaded shaft 42 and theadjustment knob 40 are integrally formed, e.g., integrally molded, as aone-piece component. However, the adjustment knob 40 and the threadedshaft 42 may be constructed in two parts and permanently orsemi-permanently assembled, e.g., by an adhesive. In the illustratedembodiment, the threaded shaft 42 includes a two-start design.

The knob 40 has two half oval finger grips 44 that make the knob 40easier to operate. The knob 40 also has two external ridges 46 that arediametrically opposed from one another. These ridges 46 may be used as avisual and kinesthetic means of aligning the knob 40 such that thecorrect forehead support position may be achieved. For example, theridges 46 may be used to indicate start/finish positions, therebyproviding tactile feedback. In the illustrated embodiment, the two-startthreads of the threaded shaft 42 align with the two ridges 46 so thatwhen the knob 40 is completely wound, the two ridges 46 extend generallyvertically.

In an alternative embodiment, one single ridge may be used to indicatethe position of the knob 40. Since the knob 40 may be assembled in twoorientations 180 degrees out of phase, i.e., due to two-start threadedshaft 42, the ridge may begin at the top or the bottom.

The adjustment knob 40 clips onto the frame connector 20 with asnap-fit. Specifically, the knob 40 includes a segment 48 that isinserted into the frame connector 20. An annular rim 50 is provided onthe segment 48 that can be engaged with retention features 24 providedin the frame connector 20 (see FIGS. 3-1 and 3-3). The segment 48includes two splits 49 that divide the segment 48 into two resilientarms 52 which can deflect to allow the rim 50, and hence the knob 40, tosnap into and out of engagement with the retention features 24. It isnoted that the annular rim 50 is thicker as it approaches the splits 49,which allows for an even force to snap the knob 40 on/off regardless ofthe knob's orientation. Also, the grips 44 and/or ridges 46 facilitateassembly and disassembly of the knob 40 to the frame connector 20.

The threaded shaft 42 is adapted to engage within the internallythreaded tube 62 of the forehead cushion support 60 such that thethreaded shaft 42 is intermeshed with the internally threaded tube 62.When the knob 40 is rotated, the internally threaded tube 62 extends orretracts from the threaded shaft 42 which causes adjustable movement ofthe forehead cushions 90.

A resilient prong 54 including a ratchet bump 56 is located within eachof the two splits 49 in the adjustment knob 40. When the knob 40 isassembled to the frame connector 20, the ratchet bumps 56 engage aseries of ridges 26 around the interior surface of the frame connector20 (see FIGS. 3-1 and 3-3). The bump/ridge engagement provides tactilefeedback in use as described below.

As best shown in FIG. 4-7, the ratchet bump 56 is angled by a withrespect to a vertical axis, e.g., 5-6 degrees. The bump 56 is angled sothat when the prong 54 and bump 56 thereof is deflected upon assembly tothe frame connector 20, an even load will be placed on the face of thebump 56. This allows more even wear on the face of the bump 56.

As best shown in FIGS. 4-3 and 4-4, each prong 54 also has an hourglassor “waisted” shape to help reduce stress on the prong 54 and preventbreakage of the prong 54 from the knob 40. The waist allows a bendingforce to be more evenly distributed along the length of the prong 54,rather than being concentrated at the proximal end of the prong 54.

In addition, the knob 40 includes a plurality of horns 58, e.g., fourhorns, around an upper periphery of the segment 48. The four horns 58facilitate centering of the knob 40 within the frame connector 20.Specifically, the horns 58 rest on an annular surface 28 within theframe connector 20 (see FIGS. 3-1 and 3-3) which acts as a smoothbearing surface.

In an embodiment, the adjustment knob 40 is constructed of a clearmicrocrystalline polyamide 12, e.g. clear Nylon 12, which is a differentmaterial than the other parts of the forehead support, e.g.,polycarbonate. This arrangement reduces noise, e.g., squeak, that wouldoccur if two polycarbonate components were used. In addition, clearmicrocrystalline polyamide 12 has the advantage of being clear.

1.3 Frame Connector

As noted above and best shown in FIGS. 3-1 to 3-6, the frame connector20 includes retention features 24 for mounting the knob 40, a series ofridges 26 that engage bumps 56 provided on prongs 54 of the knob 40, anannular surface 28 that engages the horns 58 of the knob 40, and threeprotrusions 22 for guiding the tube 62 of the forehead cushion support60.

In the illustrated embodiment, the ridges 26 include twelve crests andtroughs that engage the bumps 56 provided on prongs 54 of the knob 40.As the knob 40 is rotated, the bumps 56 ratchet or click against theridges 26 to provide indexed incremental adjustment of the foreheadsupport and to provide tactile feedback as to the location of theforehead support. In addition, the bumps 56 help to maintain theposition of the forehead support, e.g., prevent self-winding. That is,the bumps 56 will be seated within respective ridges 26 to assist inrestraining the forehead support at the desired position. In anembodiment, each click represents 1 mm of travel, with a total of 24 mmof travel available, i.e., two rotations.

As best shown in FIGS. 1-3, 1-4, 1-9, 2-6, and 3-6, the frame connector20 has a cut-out 30 at its rear which allows the upper portion of thetube 62 to be visible. This arrangement allows markings or positionlabeling to be added to the tube 62 to indicate the position of theforehead cushion support 60. Position markings are described in greaterdetail below.

2. Second Illustrated Embodiment of Forehead Support

FIGS. 6-1 to 9-8 illustrate a forehead support 212 according to anotherembodiment of the present invention. The forehead support 212 includes aframe connector 220 provided to the mask frame 14 (see FIGS. 6-1 to6-7), an adjustment knob 240 including a threaded shaft 242 (see FIGS.7-1 to 7-8), and a forehead cushion support 260 including an internallythreaded tube 262 (see FIGS. 8-1 to 8-7). Assembly (see FIGS. 9-1 to9-8) and operation of the forehead support 212 is substantially similarto the forehead support 12 described above.

2.1 Forehead Cushion Support

As shown in FIGS. 8-1 to 8-7, the forehead cushion support 260 includesan internally threaded tube 262 (e.g., see threads 263 in FIG. 8-1)joined to forehead cushion support plates 264 that carry foreheadcushions. As best shown in FIGS. 8-2 and 8-4, the support plates 264include horizontal reinforcing ribs 266 to provide better flexingstrength. Also, as best shown in FIG. 8-5, the support plates 264 areangled with respect to the tube 262, e.g., about 15-25°, or preferably21°, from vertical.

The tube 262 includes two splits 268 that divide the tube 262 into tworesilient arms 270 which can deflect to allow insertion of the tube 262into the frame connector 220. In the illustrated embodiment, the splits268 extend to the cushion support plates 264.

The internally threaded tube 262 includes key ways or elongated slots272 (e.g., three keyways) that receive respective protrusions 222 (e.g.,three protrusions) provided on the frame connector 220 (see FIGS. 6-2 to6-7). Three hole 265 are provided in the support plates 264 at the endof the key ways 272. The three holes 265 allow the three protrusions 222on the frame connector 220 to protrude through the support plates 264when the forehead cushion support 260 is retracted (e.g., see FIGS. 9-2,9-3, and 9-5). This arrangement provides a longer, more stableattachment.

As illustrated, a ridge or retention bump 274 is provided at the end ofeach key way 272. The ridges 274 force the arms 270 to deflect onassembly to the frame connector 220 and prevent inadvertent disassemblyof the forehead cushion support 260 from the frame connector 220. In theillustrated embodiment, the ridges 74 are provided at the end of thetube 262, i.e., no lead-in as in the forehead cushion support 60.

In the illustrated embodiment, the forehead cushion support plates 264include slots 276 for attaching headgear straps. The headgear straps mayinclude Velcro for length adjustment. A gap 278 is provided in eachsupport plate 264 to allow the headgear strap to be fitted withoutundoing the Velcro and losing the correct headgear length. Thisarrangement facilitates assembly and disassembly of the headgear strapsfrom the forehead cushion support plates 264.

In the illustrated embodiment, the width of the slots 276 is wider thanthose of the forehead cushion support 60. However, other suitable widthsare possible. Also, the forehead cushion support 260 may be thinner insome regions when compared to the forehead cushion support 60, e.g.,upper wall 280 of forehead cushion support 260 is thinner than that ofthe forehead cushion support 60 (see FIG. 8-6).

2.2 Adjustment Knob

Referring to FIGS. 7-1 to 7-8, the adjustment knob 240 is substantiallysimilar to the adjustment knob 40 described above. In contrast, eachprong 254 does not have an hourglass or “waisted” shape such as that ofthe prong 54 (see FIGS. 7-5 and 7-6).

As noted above, the ratchet bump 256 of each prong 254 is angled at awith respect to a vertical axis, e.g., 5-6 degrees. This arrangement ismore clearly shown in FIG. 7-4.

2.3 Frame Connector

As shown in FIGS. 6-1 to 6-7, similar to the frame connector 20described above, the frame connector 220 includes retention features 224for mounting the knob 240, a series of ridges 226 that engage bumps 256provided on prongs 254 of the knob 240, an annular surface 228 thatengages the horns 258 of the knob 240, and three protrusions 222 forguiding the tube 262 of the forehead cushion support 260.

As illustrated, the three protrusions 222 protrude from the frameconnector 220, which provides a stable connection with the foreheadcushion support 260. This arrangement is in contrast to that of theframe connector 20 in which the protrusions were provided at an interiorportion of the frame connector 20.

3. Position Markings on Forehead Support

In an embodiment, position markings may be provided on the tube of theforehead cushion support, the frame connector, and/or the adjustmentknob to indicate the forehead support's position.

3.1 Position Markings on Tube

An indicator, e.g., artwork or graphics, may be added to the tube toindicate the 24 positions of the adjustment knob (e.g., each click ofknob represents 1 mm of travel, with a total of 24 mm of travelavailable, so 24 clicks or positions). The artwork may be achieved bypad-printing (after molding). Other options for providing artwork on thetube include etching, laser-etching, and in-mould decoration (where theartwork is pre-printed on polycarbonate, die-cut, and put into the moldprior to molding).

FIG. 10-1 illustrates a forehead cushion support 360 having a tube 362with localized in-mold decoration 395. As illustrated, the in-molddecoration 395 includes spaced markings to indicate the foreheadsupport's position as the tube 362 is extended and retracted during use.The markings may extend along full length of the tube 362 and provide ahigh resolution.

FIGS. 10-2 to 10-4 illustrate forehead cushion supports 460, 560, 660including tubes 462, 562, 662 with different embodiments of pad printedartwork 495, 595, 695. As illustrated, the artwork 495, 595, 695includes spaced markings, which are numbered, to indicate the foreheadsupport's position as the tube is extended and retracted during use. Inthe illustrated embodiment, 24 markings or steps are provided, which arenumbered every three positions. This artwork provides a series of stepswhich is easily understood by the user. The forehead cushion supports460, 560, 660 are all shown in the “24” or fully extended position. Thecurrent position aligns with the bottom of the respective cut-out 430,530, 630 in the frame connector.

However, other suitable markings may be provided on the tube, e.g.,simple lines or alphabetical labeling.

FIG. 10-5 illustrates exemplary dimensions for the forehead cushionsupport 460 with artwork 495. In an embodiment A may be 5.75-6.25 mm,e.g., 6.0 mm, B may be 6.6-7.6 mm, e.g., 7.1 mm, C may be 26.2-28.2 mm,e.g., 27.2 mm, and D may be 23.95-23.45 mm, e.g., 24.2 mm. Althoughspecific dimensions and ranges are provided, it is to be understood thatthese dimensions and ranges are merely exemplary and other dimensionsand ranges are possible depending on application. For example, rangesthat vary from those provided +/−10% may be suitable for particularapplications.

3.2 Position Markings on Frame Connector and/or Adjustment Knob

Position markings may be provided to the frame connector and/or theadjustment knob to indicate the forehead support's position.

3.2.1 First Illustrated Embodiment

FIG. 11-1 illustrates an embodiment of a forehead support 712 whereinthe frame connector 720 includes a single line 784 on the top thereofand the adjustment knob 740 includes ascending bumps 786 around itsperimeter. During use, a selected one of the ascending bumps 786 on theknob 740 can be aligned with the line 784 on the frame connector 720 toindicate the forehead support's position.

In an embodiment, the bumps 786 on the knob 740 may be formed duringmolding of the knob 740 in the molding tool and the single line 784 maybe printed on the frame connector 720, e.g., by pad printing, in anysuitable color, e.g., blue. This arrangement provides position markingsthat are relatively simple to implement.

The ascending or varying height bumps 786 on the knob 740 provide gripfor turning as well as tactile feedback of the knob's position. Inaddition, alignment of the large bump on the knob 740 with the padprinted line 784 on the top of the frame connector 720 (as shown in FIG.11-1) allows the knob 740 to be assembled and calibrated correctly.

In an embodiment, the forehead cushion support 760 may include atwo-zone marking that indicates whether one is on the first rotation orthe second rotation of the knob 740. For example, as shown in FIG. 11-2,the tube 762 of the forehead cushion support 760 may include a label onthe top edge thereof that defines a first zone Z1 having a first color,e.g., white, and a second zone Z2 having a second color different thanthe first color, e.g., blue. Each color represents a full rotation ofthe knob 740 in use, e.g., 360°. That is, the tube color indicateswhether the knob is within its first rotation or its second rotation.

3.2.2 Second Illustrated Embodiment

FIG. 11-3 illustrates an embodiment of a forehead support 812 whereinthe frame connector 820 includes a printed line 884 along with texturedincrement markings 885 around its perimeter. The adjustment knob 840includes single printed line 886. During use, the line 886 on the knob840 can be aligned with a selected one of the line 884 or markings 885on the frame connector 820 to indicate the forehead support's position.

In an embodiment, the lines 884, 886 on the frame connector 820 and knob840 may be printed thereon, e.g., by pad printing, in any suitablecolor, e.g., blue. The textured increment markings 885 may be formedduring molding of the frame connector 820 for example. This arrangementprovides position markings that are relatively simple to implement.

Alignment of the relatively long pad printed line 886 on the knob 840with the relatively long pad printed line 884 on the top of the frameconnector 820 (as shown in FIG. 11-3) allows the knob 840 to beassembled and calibrated correctly. In addition, it is intuitive thatthe two pad printed lines 884, 886, e.g., blue lines, align for correctassembly and calibration.

In an embodiment, the forehead cushion support 860 may include atwo-zone marking (such as that shown in FIG. 11-2) that indicateswhether the knob 840 is on the first rotation or the second rotation.

The forehead support 812 provides an arrangement that is relatively easyto prescribe a setting. For example, the patient may be prescribed witha “white-2” which would correspond to the position P as the patientturns the knob 840 from the fully open position.

3.2.3 Third Illustrated Embodiment

FIGS. 11-4 and 11-5 illustrate an embodiment of a forehead support 912wherein the frame connector 920 and the adjustment knob 940 include anasymmetrical shape. As illustrated, the frame connector 920 and knob 940have an elongated top portion. This arrangement is relatively simple toalign, assemble and calibrate the adjustment starting point, e.g., byadjusting the knob 940 until its exterior surfaces are flush with theexterior surfaces of the frame connector 920. In addition, theasymmetrical shape provides good tactile feedback of the knob'sposition.

3.2.4 Fourth Illustrated Embodiment

FIGS. 11-6 to 11-10 illustrate an embodiment of a forehead support 1012wherein the frame connector 1020 includes a transparent window 1084 onthe top thereof (e.g., fish eye window or gloss window) and theadjustment knob 1040 includes a numeric and/or graphic scale 1086 (seeFIGS. 11-7 to 11-10) around its perimeter that is viewable through thewindow 1084. During use, a selected number and/or graphical position onthe scale 1086 of the knob 1040 can be aligned with the window 1084 onthe frame connector 1020 to indicate the forehead support's position.

In an embodiment, the exterior surface of the frame connector 1020surrounding the window 1084 may be textured. Also, the knob 1040 mayinclude a raised portion or rib 1041 to provide grip for turning as wellas tactile feedback of the knob's position.

In an embodiment, the numeric and/or graphic scale 1086 on the knob 1040may be printed thereon, e.g., by pad printing, in any suitable color.

Also, the forehead cushion support 1060 may include a two-zone marking(such as that shown in FIG. 11-2) that indicates whether the knob 1040is on the first rotation or the second rotation. This arrangement isvery prescriptive and allows fine adjustment as there would be a zoneindicated by the forehead cushion support 1060 and a number/graphicalposition in the window 1084.

FIGS. 11-7 to 11-10 illustrate alternative embodiments of the window1084 on the frame connector 1020 and/or the scale 1086 on the knob 1040.In each embodiment, the scale 1086 is provided on a portion of the knob1040 that is enclosed by the frame connector 1020 to allow the patientto read the scale 1086 through the window 1084.

In FIG. 11-7, the scale 1086 includes numbers and an ascending heightband to indicate the forehead support's position. In FIG. 11-8, thewindow 1084 is positioned more inwardly on the frame connector 1020(with respect to FIG. 11-7), e.g., near the retaining rim of the knob,and the scale 1086 includes only numbers. In FIG. 11-9, the scale 1086includes only numbers to indicate the forehead support's position. InFIG. 11-10, the scale 1086 includes only an ascending height band toindicate the forehead support's position. However, other suitable scalesand window configurations are possible.

3.2.5 Fifth Illustrated Embodiment

FIG. 11-11 illustrates an embodiment of a forehead support 1112 whereinthe frame connector 1120 includes increment recesses 1184 around itsperimeter and the adjustment knob 1140 includes a clicker 1186 that isadapted to selectively engage with the recesses provided on the frameconnector 1120. During use, the clicker 1186 on the knob 1140 can beselectively engaged within one of the recesses 1184 on the frameconnector 1120 to indicate the forehead support's position.

As illustrated, the knob 1140 includes a raised portion or rib 1141 toprovide grip for turning as well as tactile feedback of the knob'sposition.

The clicker 1186 and raised portion 1141 provide good positionalinformation that is both visual and tactile. In addition, the clicker1186 and raised portion 1141 provide an arrangement that is relativelysimple to align, assemble, and calibrate the adjustment starting point.

Also, the forehead cushion support 1160 may include a two-zone marking(such as that shown in FIG. 11-2) that indicates whether the knob 1140is on the first rotation or the second rotation. This allows a settingto be prescribed relatively easily, e.g., clicker setting along withzone on forehead cushion support.

3.2.6 Sixth Illustrated Embodiment

FIGS. 11-12 to 11-13 illustrate an embodiment of a forehead support 1212wherein the frame connector 1220 includes a printed line 1284 along withetched texture markings 1285 around its perimeter. The adjustment knob1240 includes a raised portion or rib 1241. During use, the raisedportion 1241 on the knob 1240 can be aligned with a selected one of theline 1284 or markings 1285 on the frame connector 1220 to indicate theforehead support's position.

In an embodiment, the line 1284 on the frame connector 1220 may beprinted thereon, e.g., by pad printing, in any suitable color, e.g.,blue.

The raised portion 1241 on the knob 1240 provides grip for turning aswell as tactile feedback of the knob's position. In addition, the raisedportion 1241 and relatively long pad printed line 1284 on the top of theframe connector 1220 provide an arrangement that is relatively simple toalign, assemble, and calibrate the adjustment starting point.

In an embodiment, the forehead cushion support 1260 may include atwo-zone marking (such as that shown in FIG. 11-2) that indicateswhether the knob 1240 is on the first rotation or the second rotation.

The forehead support 1212 provides an arrangement that is relativelyeasy to prescribe a setting, e.g., knob setting along with zone onforehead cushion support.

3.2.7 Seventh Illustrated Embodiment

FIG. 11-14 illustrates an embodiment of a forehead support 1312 whereinthe frame connector 1320 includes markings 1384 on the top thereof andthe forehead cushion support 1360 includes a depth gauge or positionindicator 1386 on the top thereof with a single marking 1387 that ismovable relative to the markings 1384 on the frame connector 1320. Asillustrated, the position indicator 1386 extends over a top portion ofthe frame connector 1320 and the marking 1387 is provided on a free endof the position indicator 1386. As the knob 1340 is rotated in use, theposition indicator 1386 moves relative to the frame connector 1320 andthe marking 1387 on the position indicator 1386 can be aligned with aselected one of the markings 1384 on the frame connector 1320 toindicate the forehead support's position.

In addition, the knob 1340 includes a raised portion or rib 1341 thatcan be aligned with a selected one of the markings 1385 provided aroundthe perimeter of the frame connector 1320 to indicate the foreheadsupport's position. The raised portion 1341 provides grip for turning aswell as tactile feedback of the knob's position. Further, the markings1385 help ensure that the knob 1340 is in a correct ratchet position andnot halfway between.

The raised portion 1341 and position indicator 1386 provide anarrangement that is relatively simple to align, assemble, and calibratethe adjustment starting point. Also, due to the position indicator 1386,the forehead cushion support 1360 does not need a two-zone marking (suchas that shown in FIG. 11-2).

3.2.8 Eighth Illustrated Embodiment

FIG. 11-15 illustrates an embodiment of a forehead support 1412 whereinthe frame connector 1420 includes markings 1484 on the top thereof andthe forehead cushion support 1460 includes a depth gauge or positionindicator 1486 with a single marking 1487 that is movable relative tothe markings 1484 on the frame connector 1420. As illustrated, theposition indicator 1486 has a shroud-like configuration that encloses orcovers the top of the frame connector 1420 and the marking 1487 isprovided on a free end of the position indicator 1486. As the knob 1440is rotated in use, the position indicator 1486 moves relative to theframe connector 1420 and the marking 1487 on the position indicator 1486can be aligned with a selected one of the markings 1484 on the frameconnector 1420 to indicate the forehead support's position.

In addition, the knob 1440 includes a raised portion or rib 1441 thatprovides grip for turning as well as tactile feedback of the knob'sposition.

The position indicator 1486 is sturdy and may assist in reducing and/oreliminating “rattle” between the forehead cushion support 1460 and theframe connector 1420. In addition, the position indicator 1486 makes theforehead cushion support 1460 less spindly and more integrated with themask frame, e.g., especially in the fully extended position.

In an embodiment, the markings 1484, 1487 on the frame connector 1420and the position indicator 1486 may be printed thereon, e.g., by padprinting, in any suitable color.

The raised portion 1441 and position indicator 1486 provide anarrangement that is relatively simple to align, assemble, and calibratethe adjustment starting point. Also, due to the position indicator 1486,the forehead cushion support 1460 does not need a two-zone marking (suchas that shown in FIG. 11-2).

4. Alternative Embodiment of Adjustment Knob

FIGS. 12-1 to 12-8 illustrate an adjustment knob 1540 according toanother embodiment of the present invention. The adjustment knob 1540 issimilar to the adjustment knobs 40, 240 described above. In contrast,each prong or ratchet 1554 does not have a hinged or cantileveredconfiguration such as that of the prongs 54, 254 described above.

Specifically, each ratchet 1554 has a non-cantilever configurationwherein each end of the ratchet 1554 is supported by the segment 1548.The ratchet extends in the direction of rotation of the knob 1540, e.g.ratchet 1554 moved 90° with respect to prongs 54, 254. Thus, the profileof the ratchet bump 1556 extends substantially parallel to the maskframe at peak deflection, e.g., as the bump is deflected over the peaksof the ridges on the frame connector. This arrangement ensures adistributed load over the ratchet bump 1556, rather than a concentratedload applied to the supported end of a cantilever arrangement.

In an embodiment, the ratchet bump 1556 of each ratchet 1554 is angledat a with respect to a vertical axis, e.g., about 1 degree. Thisarrangement is more clearly shown in FIG. 12-7.

In an alternative embodiment, as shown in FIG. 13, a knob may includeprongs 1654 with a hinged or cantilevered configuration wherein eachprong 1654 has a trapezoid-like shape (rather than an hourglass shapesuch as that of the prong 54). This arrangement provides the prong 1654with a relatively wide base at its proximal end to reduce stress. Theratchet bump 1656 is provided on the distal or free end of the prong1654. The remaining elements of the knob may be substantially similar tothe knob 40 described above.

5. Alternative Embodiment of Adjustment Knob and Frame Connector

FIGS. 14-1 to 15-4 illustrate an adjustment knob 1740 and a frame 1714including a frame connector 1720 for a forehead support according toanother embodiment of the present invention. The adjustment knob 1740and frame connector 1720 may be used with a forehead cushion supportsuch as that shown in FIGS. 5-1 to 5-7 for example.

As shown in FIGS. 14-1 to 14-8, the adjustment knob 1740 is similar tothe adjustment knob 40 described above. In contrast, the wall thicknessof the segment 1748 defining resilient arms 1752 inserted into the frameconnector 1720 has been increased, e.g., to about 1.85 mm. The arms 1752are thicker to substantially avoid the arms 1752 flexing too easily andthus differentiate between the force required to adjust the knob 1740and the force required to disassemble the knob 1740 from the frameconnector 1720.

The annular rim 1750 provided on the segment 1748 still engages withretention features 1724 provided in the frame connector 1720 with asnap-fit. Since the segment 1748 is thicker, an annular recess 1751 isprovided within which the retention features 1724 sit.

In addition, as best shown in FIGS. 14-5 and 14-6, each opening 1755between the arms 1752 (in which respective resilient prongs 1754 arelocated) has a generally triangular shape. In the adjustment knob 40described above, this opening has a generally T-shape. The knob 1740functions the same as the knob 40. However, the triangular geometry ofthe opening 1755 may be beneficial for ratchet forces to the frame 1714in use.

As shown in FIGS. 15-1 to 15-4, the frame 1714 and frame connector 1720thereof is similar to the frame 14 and frame connector 20 describedabove. In contrast, the retention features 1724 on the frame connector1720 have been increased in number to four retention features 1724(rather than two retention features 24 in frame connector 20). Theretention features 1724 are preferably equally spaced around the frameconnector 1720 to prevent twisting of the adjustment knob 1740 onassembly and disassembly.

6. Alternative Embodiments of Forehead Cushion Support

FIGS. 16-1 to 19-7 illustrate four alternative embodiments of theforehead cushion support shown in FIGS. 8-1 to 8-7 described above. Eachembodiment has a different design of deflection in order to allowinsertion of the tube into the frame connector.

6.1 First Illustrated Alternative Embodiment

FIGS. 16-1 to 16-7 illustrate a forehead cushion support 1860 accordingto another embodiment of the present invention. The forehead cushionsupport 1860 is similar to the forehead cushion support 260 describedabove in FIGS. 8-1 to 8-7. In contrast, the tube 1862 includes key waysor elongated slots 1872 (e.g., three keyways) with a bayonet styleconfiguration to allow insertion of the tube 1862 into the frameconnector.

Specifically, an L-shaped or bayonet style slot 1877 is provided as alead-in to each key way 1872. During assembly, the forehead cushionsupport 1860 must be twisted to guide the protrusions on the frameconnector through respective L-shaped slots 1877 and into the respectivekey ways 1872.

In addition, at least one of the key ways 1872 includes a deflectableretention member 1874 adjacent the L-shaped slot 1877 to preventinadvertent disassembly of the forehead cushion support 1860 from theframe connector. As illustrated, a slot 1879 is provided on each side ofthe retention member 1874 that allows the retention member 1874 todeflect on assembly of the tube 1862 to the frame connector.

6.2 Second Illustrated Alternative Embodiment

FIGS. 17-1 to 17-7 illustrate a forehead cushion support 1960 accordingto another embodiment of the present invention. The forehead cushionsupport 1960 is similar to the forehead cushion support 260 describedabove in FIGS. 8-1 to 8-7. In contrast, the tube 1962 includes key waysor elongated slots 1972 (e.g., three keyways) with a bayonet styleconfiguration to allow insertion of the tube 1962 into the frameconnector.

Specifically, an L-shaped or bayonet style slot 1977 is provided as alead-in to each key way 1972. During assembly, the forehead cushionsupport 1960 must be twisted to guide the protrusions on the frameconnector through respective L-shaped slots 1977 and into the respectivekey ways 1972.

In addition, at least one of the key ways 1972 includes a deflectableretention arm 1974, e.g., cantilevered arm, within the L-shaped slot1977 to prevent inadvertent disassembly of the forehead cushion support1960 from the frame connector. As illustrated, the retention arm 1974 isdeflectable towards the center of the tube 1962 on assembly of the tube1962 to the frame connector.

6.3 Third Illustrated Alternative Embodiment

FIGS. 18-1 to 18-7 illustrate a forehead cushion support 2060 accordingto another embodiment of the present invention. The forehead cushionsupport 2060 is similar to the forehead cushion support 260 describedabove in FIGS. 8-1 to 8-7. In contrast, the tube 2062 includes twovertical splits 2068 (rather than horizontal splits 268 of tube 262)that divide the tube 2062 into two resilient arms 2070 which can deflectto allow insertion of the tube 2062 into the frame connector. The splits2068 may have any suitable length along the tube 2062.

In addition, the tube 2062 includes key ways or elongated slots 2072(e.g., three keyways) with a bayonet style configuration to allowinsertion of the tube 2062 into the frame connector. Specifically, anL-shaped or bayonet style slot 2077 is provided as a lead-in to each keyway 2072. During assembly, the forehead cushion support 2060 must betwisted to guide the protrusions on the frame connector throughrespective L-shaped slots 2077 and into the respective key ways 2072.

A ridge or retention bump 2074 is provided at the end of each L-shapedslot 2077. The ridges 2074 force the arms 2070 to deflect on assembly tothe frame connector to prevent inadvertent disassembly of the foreheadcushion support 2060 from the frame connector.

6.4 Fourth Illustrated Alternative Embodiment

FIGS. 19-1 to 19-7 illustrate a forehead cushion support 2160 accordingto another embodiment of the present invention. The forehead cushionsupport 2160 is similar to the forehead cushion support 260 describedabove in FIGS. 8-1 to 8-7. In contrast, the tube 2162 includes key waysor elongated slots 2172 (e.g., three keyways) with a bayonet styleconfiguration to allow insertion of the tube 2162 into the frameconnector.

Specifically, an L-shaped or bayonet style slot 2177 is provided as alead-in to each key way 2172. During assembly, the forehead cushionsupport 2160 must be twisted to guide the protrusions on the frameconnector through respective L-shaped slots 2177 and into the respectivekey ways 2172.

In addition, at least one of the key ways 2172 includes a deflectableretention member 2174 within the L-shaped slot 2177 to preventinadvertent disassembly of the forehead cushion support 2160 from theframe connector. As illustrated, a slot 2179 is provided on each side ofthe retention member 2174 that allows the retention member 2174 todeflect on assembly of the tube 2162 to the frame connector.

7. Curved Forehead Cushion Support

In an alternative embodiment, the tube of the forehead cushion supportmay be slightly curved so that the forehead cushion support moves alonga curved or arcuate path.

While the invention has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the invention. Also, the various embodiments described abovemay be implemented in conjunction with other embodiments, e.g., aspectsof one embodiment may be combined with aspects of another embodiment torealize yet other embodiments. Further, each independent feature orcomponent of any given assembly may constitute an additional embodiment.In addition, while the invention has particular application to patientswho suffer from OSA, it is to be appreciated that patients who sufferfrom other illnesses (e.g., congestive heart failure, diabetes, morbidobesity, stroke, barriatric surgery, etc.) can derive benefit from theabove teachings. Moreover, the above teachings have applicability withpatients and non-patients alike.

1. A forehead support for a mask assembly, the forehead supportcomprising: a frame connector provided to a mask frame; a foreheadcushion support plate having a tube, said forehead cushion support platelinearly adjustable with respect to the frame connector along alongitudinal axis of the tube between retracted and extended positions;at least two protrusions and at least two corresponding keyways adaptedto prevent rotation of the forehead cushion support plate about thelongitudinal axis of the tube with respect to the frame connector; andan actuator disposed on the frame connector configured to adjustablysecure the forehead cushion support plate to the frame connector,wherein position markings are provided on the tube.
 2. A foreheadsupport according to claim 1, wherein the position markings includespaced markings.
 3. A forehead support according to claim 2, wherein theposition markings include spaced markings which are numbered.
 4. Aforehead support according to claim 3, wherein at least 4 of theposition markings are numbered.
 5. A forehead support according to claim4, wherein the position markings are intervally numbered such that eachnumbered marking is adjacent to an unnumbered marking on either side. 6.A forehead support according to claim 5, wherein the position markingsinclude artwork formed by pad-printing, etching, laser-etching, and/orin-mold decoration.
 7. A forehead support according to claim 1, whereinthe forehead cushion support plate is angled with respect to the tube.8. A forehead support according to claim 1, wherein the forehead cushionsupport plate includes at least one slot to receive a correspondingheadgear strap.
 9. A forehead support according to claim 8, wherein agap is provided in the forehead cushion support plate to allow theheadgear strap to be fitted into the at least one slot.
 10. A foreheadsupport according to claim 9, wherein each at least one slot has a widthof not more than 8 mm.
 11. A forehead support according to claim 1,wherein a ridge is provided at an end of the tube opposite the foreheadsupport cushion plate to prevent separation of the frame connector andthe forehead cushion support plate.
 12. A forehead support according toclaim 1, wherein the frame connector comprises a housing and a collardisposed internally of the housing to receive the tube and define alinear adjustment path of the forehead cushion support plate.
 13. Aforehead support according to claim 1, wherein said forehead supportcomprises polycarbonate.
 14. A forehead support according to claim 1,wherein the position markings include artwork formed by pad-printing,etching, laser-etching, and/or in-mold decoration, wherein the positionmarkings include spaced markings, wherein the position markings includespaced markings which are numbered, wherein the markings are intervallynumbered such that each numbered marking is adjacent to an unnumberedmarking on either side, wherein at least 4 of the markings are numbered,wherein the forehead cushion support plate is angled with respect to thetube, wherein the forehead cushion support plate includes at least oneslot to receive a corresponding headgear strap, wherein each slot has awidth of not more than 8 mm, wherein a gap is provided in the foreheadcushion support plate to allow the headgear strap to be fitted into theslot, wherein a ridge is provided at an end of the tube opposite theforehead support cushion plate to prevent separation of the frameconnector and the forehead cushion support plate, wherein the frameconnector comprises a housing and a collar disposed internally of thehousing to receive the tube and define a linear adjustment path of theforehead cushion support plate, and wherein said forehead supportcomprises polycarbonate.
 15. A mask assembly for supplying breathablegas to a wearer, the mask assembly comprising: a mask frame; a cushionprovided to the mask frame, said cushion adapted to form a seal with thepatient's face; an elbow assembly provided to the mask frame, said elbowassembly adapted to be connected to an air delivery tube; and a foreheadsupport according to claim
 1. 16. A mask assembly to supply breathablegas to a patient, the mask assembly comprising: a mask frame; a cushionprovided to the mask frame, said cushion adapted to form a seal with thepatient's face; an elbow assembly provided to the mask frame, said elbowassembly adapted to be connected to an air delivery tube; a foreheadsupport, said forehead support comprising: a frame connector extendingfrom an upper portion of the mask frame and having an outer housing andan internal ring supported within the outer housing; an actuatordisposed on the frame connector; a forehead cushion support, saidforehead cushion support comprising: at least one forehead cushionsupport plate to carry at least one forehead cushion; and a tube havinga distal end and a proximal end, said proximal end attached to the atleast one forehead cushion support plate, said tube slidably attached tosaid frame connector along a linear adjustment path defined by saidinternal ring such that at least the distal end of said tube is enclosedwithin said housing in an extended position and a retracted position,wherein at least two protrusions and at least two corresponding keywaysare configured to prevent the tube from rotating about its longitudinalaxis within the ring between the extended position and the retractedposition, wherein said actuator adjustably secures said tube to saidframe connector along said linear adjustment path and, wherein positionmarkings are provided on the tube to indicate a position of the tubealong said linear adjustment path.
 17. A mask assembly according toclaim 16, wherein the position markings include spaced markings.
 18. Amask assembly according to claim 17, wherein the position markingsinclude spaced markings which are numbered.
 19. A mask assemblyaccording to claim 18, wherein at least 4 of the position markings arenumbered.
 20. A mask assembly according to claim 19, wherein theposition markings are intervally numbered such that each numberedmarking is adjacent to an unnumbered marking on either side.
 21. A maskassembly according to claim 20, wherein the position markings includeartwork formed by pad-printing, etching, laser-etching, and/or in-molddecoration.
 22. A mask assembly according to claim 16, wherein theforehead cushion support plate is angled with respect to the tube asviewed from the side.
 23. A mask assembly according to claim 16, whereinthe forehead cushion support plate includes at least one slot to receivea corresponding headgear strap.
 24. A mask assembly according to claim23, wherein a gap is provided in the forehead cushion support plate toallow the headgear strap to be fitted into the at least one slot.
 25. Amask assembly according to claim 24, wherein each at least one slot hasa width of not more than 8 mm.
 26. A mask assembly according to claim16, wherein a ridge is provided at the distal end of the tube to preventseparation of the frame connector and the forehead cushion supportplate.
 27. A mask assembly according to claim 16, further comprising: atleast one forehead cushion removably attached to the forehead cushionsupport plate, wherein said at least one forehead cushion comprises onepiece.
 28. A mask assembly according to claim 16, wherein said foreheadsupport comprises polycarbonate.
 29. A mask assembly according to claim16, wherein the position markings include artwork formed bypad-printing, etching, laser-etching, and/or in-mold decoration, whereinthe position markings include spaced markings, wherein the positionmarkings include spaced markings which are numbered, wherein themarkings are intervally numbered such that each numbered marking isadjacent to an unnumbered marking on either side, wherein at least 4 ofthe markings are numbered, wherein the forehead cushion support plate isangled with respect to the tube as viewed from the side, wherein theforehead cushion support plate includes at least one slot to receive acorresponding headgear strap, wherein each slot has a width of not morethan 8 mm, wherein a gap is provided in the forehead cushion supportplate to allow the headgear strap to be fitted into the slot, wherein aridge is provided at the distal end of the tube to prevent separation ofthe frame connector and the forehead cushion support plate, wherein themask assembly comprises at least one forehead cushion removably attachedto the forehead cushion support plate, said forehead cushion comprisingone piece, and wherein said forehead support comprises polycarbonate.30. A mask assembly according to claim 16, wherein said mask assemblyfurther comprises an adjustment knob movably mounted to the frameconnector and threadably engaged with the forehead cushion support suchthat turning movement of the adjustment knob causes the forehead cushionsupport to be moved between the retracted and extended positions, theadjustment knob includes two external ridges that are diametricallyopposed to one another, the adjustment knob includes a resilient pronghaving a bump to selectively engage a series of ridges provided to theframe connector to provide indexed incremental adjustment, theadjustment knob includes a threaded shaft having a two-start design toengage with an internal thread of the tube of the forehead cushionsupport, the adjustment knob includes a plurality of horns on an annularsurface to act as a smooth bearing surface, the adjustment knob furthercomprises an annular rim to engage with a retention feature provided inthe frame connector;